The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality

Colorado Joint Replacement

Status: Enrolling

Conditions: Sleep Disturbance; Arthropathy

Treatments: Behavioral: Mindfulness Meditation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05295004

1845025

Details and patient eligibility

About

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively.

Full description

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively. We hypothesize that patients in the MM cohort will have lower PSQI scores, indicating higher sleep quality, at both post-operative time points. Secondary aims include characterizing differences between cohorts in Visual Analog Scale (VAS) for pain, Epworth Sleepiness Scale (ESS) scores, Patient Reported Outcome Measurement Information System - Sleep Disturbance - Short Form, and Knee Injury and Osteoarthritis Outcome Scores (KOOS) at 2, 6 and 12 weeks following TJA.

Enrollment: 282 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing primary unilateral total joint arthroplasty at Colorado Joint Replacement
• Between the ages of 18 and 90 years old will be included in the study.

Exclusion criteria

• Simultaneous total joint arthroplasty
• Uni-compartmental knee arthroplasty
• Revision surgery for infection, fracture or other indication.
• History of Drug or Alcohol Abuse
• Patients who are unable to present at a standard pre-operative appointment within 4 weeks prior to scheduled surgery will also be excluded, as the MM intervention would not be possible to administer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 3 patient groups

No Treatment

No Intervention group

Description:

Patient will receive no mindfulness meditation training.

Mindfulness at Pre-Op

Experimental group

Description:

Patient will receive a one time training at their pre-operative appointment.

Treatment:

Behavioral: Mindfulness Meditation Training

Multiple Mindfulness Meditation

Experimental group

Description:

Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.

Treatment:

Behavioral: Mindfulness Meditation Training